Innovaderm Shines as Key Partner in Clinical Development and Study Management of Newly FDA-Approved Psoriasis Drug, Tapinarof
2022-07-21
[MONTREAL, QUEBEC – July 21, 2022] Innovaderm’s involvement in all phases of the clinical development of tapinarof culminated with a tremendous achievement: the recent approval of Dermavant Sciences’ VTAMA® (tapinarof) cream by the FDA for the treatment of plaque psoriasis in adults.
Discovered in Canada, tapinarof is approved in the United States for the management of psoriasis, a chronic skin condition that causes itchy, scaly patches on different parts of the body and has a significant detrimental effect on quality of life.
“This is a great milestone for patients – one that we have been working towards for years,” says Dr. Robert Bissonnette, Innovaderm’s founder and CEO. “Innovaderm is well-positioned to help companies such as Dermavant drive innovation forward by accompanying them in all stages of their clinical research from protocol writing to data analysis. We not only played an instrumental role through our participation in multicenter phase 2 and 3 studies, but we were also the first to demonstrate tapinarof’s efficacy in proof-of-concept studies in both psoriasis and atopic dermatitis.”
VTAMA® cream is a once-daily, topical medication for psoriasis. Currently, clinical trials are underway to study this medication among patients with atopic dermatitis.
“VTAMA® cream is a non-steroidal topical that is a new chemical entity and the first-in-class therapy to be approved in the topical psoriasis space in 25 years,” says Anna Tallman, PharmaD, Vice-President of Medical Affairs at Dermavant Sciences. “We appreciate the collaboration and partnership with Dr. Bissonnette and Innovaderm to help bring forward an effective new treatment option in the United States that has the potential to benefit adults with plaque psoriasis across the entire disease severity spectrum – from mild to severe.”
Dr. Bissonnette and Tallman recently contributed to an article on the phase 3 tapinarof studies, which was published in the New England Journal of Medicine. To learn more, click here.
For information on Innovaderm’s early to late phase study capabilities, click here.
IMPORTANT SAFETY INFORMATION
Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist approved in the US for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or call 1-800-FDA-1088.
See full Prescribing Information and Patient Information.
Innovaderm Research Inc.
Innovaderm Research Inc. is a global, full-service CRO specialized in therapeutic dermatology. Founded in 2000, it partners with biotechnology and pharmaceutical companies for the collaborative management of early to late phase clinical trials. Its mission is to drive innovative research initiatives and offer new therapies for patients living with skin disease.
Dermavant Sciences
Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes both approved and late-stage development product candidates the company believes may address important immuno-dermatological conditions, including plaque psoriasis and atopic dermatitis. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).
Original Article:
Businesswire.com
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